Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

March 23, 2010 updated by: Butler Hospital

Smoking Cessation Among Methadone Maintained Patients

RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.

PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.

OUTLINE: Patients are assigned to 1 of 2 groups.

  • Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
  • Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.

All patients will be offered a 2- to 3-month supply of nicotine patches.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Must be currently enrolled in a methadone maintenance program
  • Smokes at least 10 cigarettes a day

PATIENT CHARACTERISTICS:

  • Not pregnant
  • No concurrent medical condition that precludes the use of nicotine patches

PRIOR CONCURRENT THERAPY:

  • No concurrent use of other nicotine replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nicotine Abstinence
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Stein, MD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000452798
  • R01CA084392 (U.S. NIH Grant/Contract)
  • RIH-0076-98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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